Aspivix's Carevix Device Wins MHRA Approval – A Game Changer For Women's Health

Aspivix has revealed that its Carevix device has received approval from the Medicines & Healthcare products Regulatory Agency (MHRA) for use across the United Kingdom. According to Aspivix, this achievement represents a crucial milestone for the company and highlights its dedication to 'modernising gynecology' as part of its mission, 'Gynecology. Now Modern.' The company asserts that Carevix aims to 'set new standards' in gynecological care, enhancing comfort and empowerment for both patients and healthcare professionals in transcervical procedures, including IUD/coil insertions, and applications in gynecology, oncology, and fertility.

Mathieu Horras, CEO & Co-Founder of Aspivix, said in a statement, "Receiving MHRA approval is not just an achievement for Aspivix but a victory for women's healthcare globally. This endorsement allows us to bring Carevix to the UK market, further expanding our reach and impact on women's health. With existing FDA approval for the US and CE Mark for Europe, we are poised to make significant advancements in gynecological care."

Aspivix is committed to enhancing women's experiences by prioritizing minimally invasive and patient-centered approaches. Their goal is to reduce the pain and bleeding commonly linked with gynecological transcervical procedures, including coil fittings, hysteroscopies, and endometrial biopsies. Women can now access the Carevix device at Peterborough City Hospital, part of the North West Anglia NHS Foundation Trust.

Dr. Lukasz Polanski, an esteemed member of the Royal College of Obstetricians and Gynaecologists, mentioned, “Carevix looks like an excellent product and our team at Peterborough City Hospital is very happy to join the program. I’m sure the patients would love it.”

Peterborough City Hospital has now been designated as the 17th center of excellence to join the Carevix Ambassador Program. This initiative enables OB-GYNs, midwives, and nurses across various countries—including the US, Brazil, France, Sweden, Switzerland, Germany, and Italy—to incorporate Carevix into their routine gynecological practices. Aspivix reports that more than 600 patients globally have already experienced the benefits of Carevix through this program.